(HealthDay News) — Linagliptin is noninferior to glimepiride for adults with relatively early type 2 diabetes and elevated cardiovascular risk, according to a study published online in the Journal of the American Medical Association to coincide with the annual meeting of the European Association for the Study of Diabetes, held from Sept. 16 to 20 in Barcelona, Spain.
Julio Rosenstock, MD, from the Dallas Diabetes Research Center at Medical City, and colleagues examined cardiovascular outcomes of linagliptin versus glimepiride (sulfonylurea) in 6042 adults with type 2 diabetes, glycated hemoglobin of 6.5 to 8.5%, and elevated cardiovascular risk. Patients were followed for a median of 6.3 years.
The researchers found that the primary outcome (time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) occurred in 11.8 and 12.0% of patients in the linagliptin and glimepiride groups, respectively (hazard ratio, 0.98; 95.47% confidence interval, 0.84 to 1.14; P<0.001 for noninferiority), meeting the criteria for noninferiority but not superiority (P = 0.76). Adverse events occurred in 93.4 and 94.9% of patients in the linagliptin and glimepiride groups, respectively, with adjudicated-confirmed acute pancreatitis in 0.5% of each group. Overall, 10.6 and 37.7% of the linagliptin and glimepiride groups had at least 1 hypoglycemic event (hazard ratio, 0.23; 95% confidence interval, 0.21 to 0.26).
“The current study demonstrates noninferior cardiovascular safety effects for linagliptin versus glimepiride when used predominantly as a second-line glucose-lowering treatment option after metformin,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Boehringer Ingelheim, which manufactures linagliptin and funded the study.
Rosenstock J, Kahn SE, Johansen OE, et al. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial (published online September 19, 2019). JAMA. doi:10.1001/jama.2019.13772